Best Practices for Preparing for a Technical File for CE Mark 2015 is a webinar that covers topics such as:
- Overview of EU Directives
- How EU laws are made
- Active Implantable Medical Device Directive (AIMDD)
- Medical Device Directive (MDD)
- 2007/47/EC Amending MDD and AIMDD
- In Vitro Diagnostic Device Directive (IVDD
- Device Classification
- CE Marking Principles
- Content of Declaration of Conformity
- Contents and Format for a Technical File And Design Dossier
- Overview of ISO 13485, ISO 14155, And ISO 14971
- Clinical Evaluation
- PASS-IT Recommendations/Suggestions
- GHTF/IMDRF and MEDDEV Guidance Documents
Best Practices for Preparing for a Technical File for CE Mark 2015 is intended for:
- VPs
- CEOs
- Attorneys
- Compliance officers
- Regulatory affairs (associates, specialists, managers, directors or VPs)
- Clinical affairs (associates, specialists, managers, directors or VPs)
- R&D (engineers, scientists, managers, directors or VPs)
- Quality assurance (associates, specialists, managers, directors or VPs)
- Consultants
- CROs
- Contractors/subcontractors
